Type 2 Diabetes
Conditions
Brief summary
There is substantial evidence supporting the fact that ectopic fat accumulation is an important contributor to type 2 diabetes complications and cardiovascular risk \[1\]. Epicardial adipose tissue (EAT), located between the myocardium and the visceral layer of the pericardium has been associated with atrial fibrillation and with coronary artery disease \[2, 3\] and its abundance predicts the number of cardiac events within 8 years \[4\]. In addition, myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction \[5\] \[6\]. Furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac ectopic fat accumulation and improve cardiac function \[7\] \[8\]. When added to standard care, 10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (iSGLT2), significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart failure among individuals with type 2 diabetes and established cardiovascular disease when compared to placebo \[9\]. The mechanisms of empagliflozin-improved cardiovascular outcomes in type 2 diabetic patients at high risk of cardiovascular events are not known. We hypotheses that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2 diabetic patients.
Interventions
1 tablet of 10 milligrams per bone 1 time a day during 12 weeks
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years, * Type 2 diabetes based on the disease diagnostic criteria as described by the WHO, * HbA1c \> 7% and \< 10 % * Stable glucose-lowering therapy for at least 3 weeks before randomization * Estimated glomerular filtration rate \> 60/ml (MDRD) * Signed informed consent form obtained prior to any study procedure
Exclusion criteria
* Evolutive or planned pregnancy during the six months * Lactation * Recent weight loss (\>5% of body weight within one month), * Treatment modifying adipose distribution such as corticoids * Acute coronary syndrome or instable angina during the last 2 months, * MRI contraindication (metal cardiac valve, pace maker, metal foreign body, claustrophobia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiac morphology | 12 weeks | magnetic resonance imaging |
| epicardial adipose tissue volume | 12weeks | magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| myocardial triglyceride | 12weeks | proton magnetic resonance spectroscopy |
| hepatic triglyceride content | 12 weeks | proton magnetic resonance spectroscopy |
| myocardial PCr/ATP ratio | 12 weeks | — |
Countries
France
Outcome results
None listed